Pfizer Inc. (NYSE:PFE) and partner Arvinas Inc. (NASDAQ:ARVN) shares rose Monday after the companies secured a key regulatory win, with the U.S. Food and Drug Administration approving VEPPANU (vepdegestrant) for the treatment of advanced breast cancer.
The approval covers estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
On Friday, the FDA approved VEPPANU, a first-of-its-kind PROTAC therapy aimed at treating adults with estrogen receptor-positive, HER2-negative advanced breast cancer.
The approval, ahead of the FDA’s assigned PDUFA date of June 5, 2026, marks a pivotal moment for Pfizer as it continues to expand its oncology portfolio.
VEPPANU was discovered by Arvinas and jointly developed by Arvinas and Pfizer.
Phase 3 Data Shows Improvement In Progression-Free Survival
FDA approval was based on data from the VERITAC-2 Phase 3 trial evaluating vepdegestrant versus fulvestrant.
In the trial, among patients with an ESR1 mutation, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 43% compared to fulvestrant.
Median PFS was 5 months in the vepdegestrant arm and 2.1 months in the fulvestrant arm.
Overall survival was immature, with 16% of deaths in this population at the time of the PFS analysis.
Companion Diagnostic Approval Adds Patient Identification Tool
On Monday, the FDA approved Guardant Health Inc.’s (NASDAQ:GH) Guardant360 CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant).
The approval of Guardant360 CDx enables a non-invasive, blood-based method to identify patients with ESR1 mutations who may be eligible for treatment with VEPPANU.
Price Action: Arvinas shares were up 1.62% at $10.10 and Pfizer shares were up 0.32% at $26.41 at the time of publication on Monday, according to Benzinga Pro data.
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